Director, GCP Process Excellence

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Job Description
OBJECTIVES/PURPOSE:
Global Development Compliance ensures quality and regulatory adherence across clinical development by collaborating with R&D Quality and R&D Good Clinical Practice (GCP) functions. By advocating for the adoption of our Future Fit Ways of Working, we endeavor to drive continuous improvement, stimulate innovation, and establish an efficient, inspection-ready clinical trial delivery operating model. Recognizing technology and automation as essential priorities, we aim to leverage digital tools to enhance efficiency, streamline processes, and accelerate the delivery of our drug pipeline, thereby bringing medicines to patients more swiftly.
The Director of GCP Process Excellence is tasked with overseeing compliance with the global leadership and strategic direction for the Quality Management System (QMS) and the Standard Operating Procedure (SOP) development and maintenance strategy for clinical trial delivery, in coordination with R&D Quality Assurance (QA). The Director will employ innovative methodologies and foster new ideas from subject matter experts to optimize clinical trial delivery process efficiency, taking into account the interplay of people, processes, and technology. This role will execute on the strategy for end-to-end process development and continuous improvement framework. This will include collaborating with Functional Leaders, Business Process Owners (BPOs), and departments like R&D Quality, Ethics, and Compliance, to define, develop, and operationalize SOPs, support implementation, and ensure regulatory compliance.
ACCOUNTABILITIES:

• Partner with other Global Development Compliance functions, R&D QA, BPOs and functional leadership to ensure delivery of the end-to-end processes for incorporating Future Fit ways of working to enable the clinical trial delivery operating model (analyze, design, develop, implementation, adoption, change management etc.).
• Execution of the QMS SOP framework for clinical trial delivery, ensuring ongoing engagement of R&D QA, BPOs, stakeholders (internal and external) and functional leadership
• Work with R&D QA, functional leaders, BPOs and stakeholders (internal and external) to confirm business impact is well-understood and accountabilities are clearly defined
• Enable capabilities to maximize clinical trial delivery process definition and development efficiency, looking for opportunities for continuous improvement in our ways of working
• Facilitate the Business Process Owner (BPO) and Business System Owner (BSO) Network to ensure consistency and effective connections between business process and system process in clinical trial delivery
• Partner with GCP Functions to drive optimization activities and initiatives to ensure proper support (change management, training, adoption) is applied for successful implementation
• Provide support on QA QMS Initiatives
• Ensure process changes are incorporated as required by regulation or CAPAs
• Provide support for inspections and internal audits

CORE ELEMENTS RELATED TO THIS ROLE:

• Experience with the pharmaceutical Industry, including research and development and clinical trials conduct
• Strong understanding of business process development and documentation best practices
• Visibly engage across the organization to ensure transformational impact
• Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing
• Provide input to highly complex decisions that impact overall R&D
• Ability to seek diverse input from multiple stakeholders to drive innovative solutions
• Ability to incorporate feedback and ensure decisions are implemented swiftly to yield flawless execution
• Forward thinking with the ability to recommend, influence and implement organizational change and continuous innovation
• Identifies opportunities and anticipates changes in the business landscape through an understanding and ongoing assessment of the environment affecting the business
• Enables strategies for effecting change, controlling change, and helping people to adapt to change
• Proactively identifies and communicates issues before they arise and develops contingency plans
• Ability to work in a global organization with a high degree of complexity and understand broader, enterprise level perspective
• Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization, creating a culture that fosters innovation

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• BS, MS or equivalent
• Minimum of 10+ years experience in pharmaceutical, CRO, healthcare or related industry
• Minimum of 5+ years experience with QMS and process development for clinical trial delivery
• Deep knowledge and/or experience within clinical trial delivery operations and clinical trial lifecycle
• Solid understanding of US CFR, GCP, ICH regulations and the clinical development process
• Experience in problem solving, negotiations and collaborative team building with peers and other stakeholders is required
• Demonstrated ability to positively influence outcomes, key project decisions, and strategic problem-solving
• Proven ability to communicate clearly and present key information objectively to all levels of the organization including executive management
• Experience in stakeholder relationship management; Influential in orchestrating key stakeholders and project teams to turn vision into reality
• Experience with matrix organization, business projects, multi-disciplinary teams or strategic change management projects
• Excellent oral and written communication skills, business acumen, and enterprise knowledge
• Understand design thinking and can explain and convince stakeholders
• Work with virtual teams in different locations, aligning and adapting different work, culture, and communication styles
• Function well under pressure in a changing environment

Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Massachusetts - Virtual
U.S. Base Salary Range:
$174,500.00 - $274,230.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Locations
Massachusetts - Virtual
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Job Exempt
Yes
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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